Autophagy Induction After Bortezomib for Myeloma

Completed · Early Phase 1

Conditions studied: Multiple Myeloma

In brief

The purpose of this study is to better understand the effects of the chemotherapy medication bortezomib on cancer cells. The investigators are therefore taking blood and bone marrow samples from patients with myeloma who are receiving bortezomib to see if the investigators can detect autophagy in the myeloma cells from the bone marrow and in immune cells in the blood. Subjects are eligible if their doctor is planning to treat them with bortezomib for the first time for their myeloma.

Key facts

Study ID

NCT01594242

Run by

Abramson Cancer Center at Penn Medicine

People needed

11

Starts

2012-07-10

Expected to finish

2015-03-02

Last updated by the study team

2019-04-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed multiple myeloma (both newly diagnosed and relapsed patients are permitted)
• No more than one line of prior therapy containing bortezomib. No prior therapy with any other proteasome inhibitor.
• For subjects who received previous bortezomib, at least a partial response while on the bortezomib-containing therapy, without progression while on bortezomib-containing therapy or within 90 days of stopping bortezomib.
• Planned therapy, as determined by the patient's treating physician, with a bortezomib-containing regimen
• Medically suitable to undergo study procedures, including a one-week washout of prior therapy, one week of observation, and one week of single-agent bortezomib
• Provision of written informed consent

You may not qualify if…

• Age <18 years (though the demographics of myeloma make it highly unlikely that any children will meet inclusion criteria)
• Treatment with other anti-myeloma agents, including corticosteroids, thalidomide, or lenalidomide, within the 7 days prior to the study baseline bone marrow biopsy.
• Inability to understand the informed consent document or unwillingness to consent.
• Written informed consent must be obtained from all patients before study entry.

Where it is running

• Abramson Cancer Center of the University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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